The Chinese-made Sinopharm vaccine became the latest COVID-19 vaccine to receive an Emergency Use Listing from the World Health Organization (WHO) on Friday; experts said the vaccine showed an overall efficacy rate of 79% in preventing symptomatic and serious disease. 

The WHO approval positions Sinopharm to become a major player in the COVAX global facility. The facility, co-sponsored by WHO and Gavi, the Vaccine Alliance, is struggling to provide desperately needed vaccine supplies to low- and middle-income countries in the wake of India’s COVID surge – which forced Indian vaccine manufacturers to divert production to domestic needs.  

It remains to be seen, what kind of deal the Beijing-based pharma company might negotiate with COVAX. The vaccine’s state-controlled developers, Beijing Bio-Institute of Biological Products, have so far pursued only bilateral vaccine donations or deals – with an official sales price exceeding that of the pricey Pfizer and Moderna vaccines – whose efficacy is much higher. 

At a press briefing on Friday, it was clear that WHO officials are keen to call on Sinopharm’s participation.

“This expands the list of vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer the vaccine,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General, at a Friday press briefing announcing the move.  

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products, said in a press release.

“From the very beginning, in all of our conversations with this company, it has been very interested in looking at playing a role to help with the global response, which is encouraging,” said Bruce Aylward, WHO Senior Advisor to the Director-General and lead on the ACT-Accelerator. 

He noted that the pharma company has also made significant efforts to expand its manufacturing capacity from the low double digit numbers to high three digit numbers to be positioned to export large numbers of doses. 

Appeal to G-7 to Close Grave, Immediate Vaccine Shortfall in LMICs

Meanwhile, WHO officials issued their second plea this week to the G-7 group of industrialized nations, meeting 11-13 June, to share excess vaccine doses with COVAX that they are holding in reserves – so the highest risk groups in low-income countries can be vaccinated. 

“Nearly 1.25 billion doses of COVID-19 vaccines have been administered globally, however, only 5 million of those have been in the lowest income countries” said Aylward. “Over 80% of the vaccines distributed have gone to high income countries and only 0.3% have been delivered to low income countries.”

“We need the help of the G7 to change that equation and raise the proportion of the populations that are vaccinated,” Aylward said.  

A bigger G-7 financial commitment is also required to combat the current “unacceptable” divide in vaccine distribution, stressed WHO officials at the biweekly press conference. 

“For G-7 now, the most important and the immediate support we need is vaccines [and] vaccine equity,” said Dr Tedros.

“The industrial and financial weight of the G-7 in supporting that is going to be absolutely crucial,” said Alyward. He warned that “we could be in a different position much faster globally than we will [otherwise] be, if we get that support through the financing, the sharing, and the scaling up of these products.”

The ACT-Accelerator, a global collaboration to accelerate the development, production, and equitable access to COVID-19 vaccines and technologies, currently is facing a financing gap of US$19 billion, which is slowing the procurement and delivery of vaccines to countries in dire need, the WHO officials said. 

Along with vaccines, funding is also needed to  scale-up of up production of other countermeasures, including diagnostics, oxygen, and PPE. 

“Without that financing or without those donations, there simply aren’t the doses that are needed to assure that countries that are really [relying on] the COVAX facility can achieve the impact” of immunity, said Dr Kate O’Brien, WHO Director of the Department of Immunization, Vaccines and Biologicals.

The comments came as WHO also reported on the first meeting of  a new “Health for All” collaboration of 11 top economists and health experts – tasked with articulating new strategies for injecting health goals into the heart of global finance, not only for medicines and vaccines access but also in terms of economic recovery. 

Sinopharm Approved For Older People – Although Clinical Trials Included Few People 60+ 

The Sinopharm vaccine had an efficacy rate of  79% in clinical trials, with respect to prevention of symptomatic disease and hospitalizations, the WHO review by the Strategic Advisory Group of Experts on Immunization (SAGE) found. Their review also included on-site inspections of the production facility.

The sixth vaccine to receive WHO’s approval, it is based on a traditional vaccine technology that delivers an inactivated form of the virus to provoke immunity. It’s cold chain storage requirements make it suitable for distribution in low-income countries. 

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” Simão said. 

WHO’s approval included a recommendation for use in adults of any age over the age of 18 – despite the admittedly scarce data from clinical trials on adults over the age of 60. 

“There is no reason to think that the vaccine would behave differently in this older age group, and in fact, in many countries in the world where the vaccine is already being used, this group has already been vaccinated,” said Dr Alejandro Cravioto, Chair of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE).

However, WHO officials said that they would encourage those in charge of country vaccination programs to implement strong followup programs to monitor the safety and efficacy of the vaccine in those over 60 years old, as well as in people with comorbidities, and pregnant women. 

“Once we have this information then, as with any other vaccine that SAGE has reviewed, we will look at the new evidence and make changes in our interim recommendations for this vaccine,” said Cravioto. “But for now, after getting an EUL approval we see no reason why this vaccine should not be recommended fully for use in people 18 years and above, in a dosage of two doses, from two to three weeks apart.”

The Sinovac vaccine, another Chinese developed COVID-19 vaccine, was also expected to receive WHO Emergency Use Listing this week, according to a statement made by Simao at the press conference on Monday. But on Friday, officials said it remains under review.

The Sinovac vaccine has in the past reported varying efficacy results in its clinical trials, ranging from 50% to 84%. SAGE had requested additional information from the manufacturer and was awaiting a response, WHO said.

Image Credits: Sinopharm, WHO.